Methods of tissue reconfiguration

ABSTRACT

An endoluminal treatment device and method includes introducing an endoluminal device into a lumen of a patient and engaging a wall of the lumen with an implant device. The implant device can be a drug delivery device or medical device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Patent ApplicationNo. 60/849,414, filed Oct. 4, 2006, which is incorporated by referenceherein in its entirety.

TECHNICAL FIELD OF THE INVENTION

Generally, the present invention is related to endoluminal surgicaldevices, methods, device, and drug delivery. More particularly, thedevices and methods provide for endoluminal gastric restriction,endoluminal gastric tissue reconfiguration, endoluminal drug delivery,endoluminal device delivery, and the like.

BACKGROUND OF THE FIELD OF THE INVENTION

Laparoscopic surgery has greatly reduced the size and scope of incisionsmade in a patient and resulted in reduced morbidity and mortality rates.However, even with the reductions in the size and scope of incisions asa result of laparoscopic surgery, complications in and during surgicalprocedures remain. A technique that is developing to further reducesurgical complications is to work through an endoluminal access port.One endoluminal access port is the mouth and this access port can give asurgeon access to a patient's esophagus and stomach.

Stomach tissue often needs surgical treatment to treat fistulas and toclose transgastric incisions to stop stomach fluids from leaking fromthe stomach to surrounding tissue and to stop infectious matter fromspreading from or to the stomach tissue. Other stomach treatmentsinclude stomach reduction procedures for obese patients. Traditionally,physicians have been placing devices such as the Lap Band® on theexternal surface of the gastric wall to create a restricted stomachcapacity. Another traditional procedure for stomach reduction includes alaparoscopic procedure in which surgeons protrude into the stomach fromthe exterior of the patient and staple the stomach into a smallervolume. This restriction creates a pouch inside the stomach which fillsquickly when food is ingested and assists in generating a sensation ofbeing full. However, these procedures have drawbacks such ascomplications from port punctures of the stomach, large incisions,substantial recovery time, expense, lost productive work time,infection, and the like.

However, the incision required by the current surgical proceduresinclude a morbidity and mortality rate that can be reduced by reducingor eliminating the need for an incision by approaching the surgical sitethrough endoluminal procedures.

SUMMARY OF THE INVENTION

According to an embodiment, the present invention includes an implantdevice including a medical implant configured to be implanted into alumen of a body without creating an incision in the body, wherein themedical implant is configured to maintain a plication in a wall of thelumen and wherein the medical implant includes a medical treatment. Themedical treatment can include a drug delivery, a time released drugdelivery, a coating, a biological stimulation device, a monitoringdevice, a feeding tube, a bioresorbable material, and combinationsthereof. The biological stimulation device can be selected from thegroup consisting of an electrical stimulation device, mechanicalstimulation device, vibratory device, sound device, ultra-sound device,chemical stimulatory device, neuro-transmitter stimulation device,thermal stimulation, sensory stimulatory device, and combinationsthereof.

In some embodiments, the implant device further includes a controllerconfigured to control the biological stimulation device. The controllercan control the biological stimulation device from external to the bodyand through radio frequency. The monitoring device can be selected fromthe group of a pH sensor, pressure sensor, video sensor, chemicalsensor, hormone sensor, dilation sensor, fluid sensor, ion sensor,tissue extension sensor, and combinations thereof. In some embodiments,the medical treatment includes material selected from radioactivematerial, chemotherapy material, biological material, and combinationsthereof.

In some embodiments, the medical treatment is configured to treat agastric condition. In some embodiments, the medical implant is includesbioresorbable material including a drug.

In alternative embodiments, an endoscopic treatment method includesintroducing an endoscopic device into a lumen of a patient withoutcreating an incision in the patient, engaging a wall of the lumen withan end effecter of the endoscopic device to form a plication, andactivating the end effecter to secure the plication with an anchorobject and a treatment device, wherein the treatment device is coupledwith the anchor object.

In some embodiments, an endoscopic treatment method includes introducingan endoscopic device into a lumen of a patient without creating anincision in the patient, introducing a treatment device into the lumen,engaging a wall of the lumen with an end effecter of the endoscopicdevice, forming a first plication in the wall of the lumen, forming asecond plication in the wall of the lumen adjacent the first plication,and coupling the first plication with the second plication to therebyform a first double plication wherein an open pocket is formed betweenthe first plication and the second plication. In alternativeembodiments, the method includes forming a second double plicationadjacent the first double plication, wherein a second open pocket formedby the second double plication and the open pocked formed by the firstdouble plication are axially aligned. In other embodiments, the methodincludes forming an artificial biological tube by aligning multipledouble plications such that open pockets formed by the multiple doubleplications axially align. In some embodiments, the method includescoupling the first double plication with the second double plication.

According to yet other embodiments, an endoscopic GERD treatment methodincludes introducing an endoscopic device into a lumen of a patientwithout creating an incision in the patient, engaging a wall of thelumen with an end effecter of the endoscopic device, and forming aplication in the wall of the lumen near the gastro-esophageal-junctionsuch that an artificial biologic tube is formed distal to thegastro-esophageal-junction to block gastric fluid from interfering withtissue of the esophagus. In some embodiments, the method includesforming a plurality of plications extending distally from thegastro-esophageal-junction. In some embodiments, the artificial biologictube is between about 0.5 cm and about 5 cm in length. In alternativeembodiments, the artificial biologic tube is between about 0.5 cm andabout 3 cm in diameter. In further embodiments, the plurality ofplications is coupled together with glue, suture, wire, or tissuere-growth after stimulation.

In other embodiments, an endoscopic obesity treatment method includesintroducing an endoscopic device into a stomach of a patient withoutcreating an incision in the patient, engaging a wall of the stomach withan end effecter of the endoscopic device, and forming a plication in thewall of the stomach such that an artificial biologic tube is formedwithin the stomach of the patient and thereby reducing a volume of thestomach to treat obesity.

In alternative embodiments, a medical implant apparatus includes ananchor object configured to couple with tissue and an adjustablemechanism configured to interact with the anchor object such as to applyalternative forces upon the anchor object in response to a stimulus. Insome embodiments, the adjustable mechanism is coupled with the anchorobject through suture material. In other embodiments, the adjustablemechanism is coupled with the anchor object through surgical wire. Insome embodiments, the adjustable mechanism shortens in response to astimuli. In some embodiments, the adjustable mechanism includes amechanism selected from the group consisting of: piezoelectric,magnetic, screw-threads, spring, memory metal, elastic, mechanicalmechanism, temperature sensitive material, and combinations thereof.According to some embodiments, the stimuli is selected from the group ofa radio frequency, ultra-sound, mechanical force, pressure, directmechanical manipulation, magnetic force, chemical interaction, enzymeinteraction, fluid, temperature, biological fluid, cellular interaction,cellular by-product, inter-cellular constituent, intra-cellularconstituent, food, digestion by-product, a lapse of time, andcombinations thereof. In some embodiments, the device further includes aplurality of anchor objects wherein each anchor object is coupled withthe adjustable mechanism such that an adjustable substantially sphinctershaped tissue structure is formed.

According to some embodiments, a method for temporary tissuerestructuring includes implanting an anchor object onto tissue to beadjustably restructured, associating an adjustable mechanism with theanchor object such that a force generated by the adjustable mechanismcan change a relative position of the anchor object with respect to theadjustable mechanism and thereby restructures tissue, and stimulatingthe adjustable mechanism to generate the force. In some embodiments, themethod further includes a plurality of anchor objects, wherein eachanchor object is coupled with the adjustable mechanism. The plurality ofanchor objects can be coupled in series with the adjustable mechanism.In some embodiments, the method includes shortening the adjustablemechanism in response to a stimuli and thereby resulting in a distancebetween the adjustable mechanism and the anchor object reducing such asto tighten tissue between the anchor object and the adjustablemechanism. In other embodiments, the adjustable mechanism includes amechanism selected from the group of: piezoelectric, magnetic,screw-threads, spring, memory metal, elastic, mechanical mechanism,temperature sensitive material, and combinations thereof. In someembodiments, the stimulating is selected from a radio frequency,ultra-sound, mechanical force, pressure, direct mechanical manipulation,magnetic force, chemical interaction, enzyme interaction, fluid,temperature, biological fluid, cellular interaction, cellularby-product, inter-cellular constituent, intra-cellular constituent,food, digestion by-product, a lapse of time, and combinations thereof.

According to alternative embodiments, the present invention discloses asurgical tool support system that includes an anchor object configuredand dimensioned to be attached to a body tissue and a manipulation lineextending from the anchor object and configured and dimensioned tocouple with a surgical tool. In some embodiments, the manipulation lineis fabricated from one of the group of a suture, resorbable suture,stainless steel, surgical wire, braided wire, and combinations thereof.

In alternative embodiments, the present invention also includes a methodof manipulating a surgical tool including forming an incision in bodytissue, attaching a manipulation line to body tissue near the incision,introducing a surgical device through the incision in the body tissue,attaching a free end of the manipulation line to the surgical device,and manipulating the surgical tool to perform a medical treatmentprocedure. The manipulation line can provide a cantilever for thesurgical tool. The manipulation line at least partially supports thesurgical device. In some embodiments, method includes implanting aplurality of manipulation lines between the body tissue and the surgicaltool. The plurality of manipulation lines are evenly distributed aroundthe surgical tool.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a schematic view of an endoluminal surgical deviceaccording to an embodiment of the present invention;

FIG. 2 shows a schematic view of a tissue engaging end effecter of anendoluminal surgical device according to an embodiment of the presentinvention;

FIG. 3 shows an implanted device according to an embodiment of thepresent invention;

FIG. 4 shows an device positioned on an end effecter prior toimplantation according to an embodiment of the present invention;

FIG. 5 shows a tissue plication including an implanted device accordingto an embodiment of the present invention;

FIG. 6 shows another device positioned on an end effecter prior toimplantation according to an embodiment of the present invention;

FIG. 7 shows another tissue plication including an implanted deviceaccording to an embodiment of the present invention;

FIG. 8 shows yet device positioned on an end effecter prior toimplantation according to an embodiment of the present invention;

FIG. 9 shows another tissue plication including an implanted deviceaccording to an embodiment of the present invention;

FIG. 10 shows an end effecter with a tissue plication formed on a needleof the end effecter according to an embodiment of the present invention;

FIG. 11 shows an end effecter with multiple tissue plications formed ona needle of the end effecter according to an embodiment of the presentinvention;

FIGS. 12A-12C show embodiments of a tissue plication and correspondingopen tissue pocket according to embodiments of the present invention;

FIGS. 13A and 13B show implanted devices according to other embodimentsof the present invention;

FIG. 14 shows an implanted device according to another embodiment of thepresent invention;

FIGS. 15A and 15B show an adjustable implantable device according to anembodiment of the present invention;

FIG. 16 shows a surgical device stabilization device according to anembodiment of the present invention; and

FIG. 17 shows a guide wire for guiding a tissue retractor according toan embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

An endoluminal device 100, such as that shown in FIG. 1 and disclosed inU.S. Pat. Nos. 6,835,200; 6,821,285; 6,773,441; 6,663,639; 6,506,196;and 6,494,888, and U.S. Published Application Nos. 2005/0033328;2004/0194790; 2004/0193194; 2004/0193193; 2004/0193184; 2004/0193117;2002/0193816; and U.S. Provisional patent application No. 60/741,510filed Dec. 1, 2005, the disclosure of each being hereby incorporated byreference in their entirety, is utilized in the present invention tomanipulate tissue of a patient. Generally, the endoluminal device 100 isconfigured such that it can be positioned within a hollow organ by entrythrough a body cavity opening, such as for example, positioning thedevice into the stomach via the mouth of a patient. Once situated, thedevice is capable of manipulating tissue and implanting objects ordevices.

According to some embodiments of the present invention, methods anddevices are provided for delivering devices or drugs into the lumen ofan organ, manipulate tissue, close incisions, repair fistulas, and thelike by an endoluminal approach. The tissue of an organ, such as forexample, the stomach, can be manipulated to generate a fold, plication,or tube and a suture based implant can be implanted to maintain themanipulated character of the tissue. In some embodiments, a drug ordevice can also be introduced into the lumen of the organ and implantedor attached to the organ wall with a suture based implant. In someembodiments, after the tissue is manipulated into folds or plicationsthe folds can be positioned vertically with respect to each other andthe suture based implants can be drawn together such as to form anartificial biological tube.

Referring to FIG. 1, endoluminal surgical device 100 is shown accordingto an embodiment of the present invention. Endoluminal surgical device100 further includes a generally longitudinal and flexible shaft 102that includes an end effecter 200 (FIG. 2) configured near its distalend. End effecter 200 includes first arm 202 and second arm 204. Firstarm 202 and second arm 204 are configured to engage tissue and implantanchor object 220. According to some embodiments, anchor object 220generally includes pledgets 222 and 224 which, according to someembodiments, are connected by suture 226. Endoluminal surgical device100, end effecter 200, and anchor object 220 are further disclosed inthe reference publications and applications that are incorporated hereinby reference. As described in further detail in the publications andapplications incorporated herein by reference, anchor object can beconstructed from any biocompatible material, such as, but not limitedto, stainless steel, cobalt chromium, titanium, alloys of such metals,biocompatible polymers, soluble polymers, non-soluble polymers,swellable polymers, absorbable polymers, suture material, bioresorbablesuture, bioabsorbable suture, combinations thereof, or the like.

Referring now to FIG. 3, endoluminal surgical device 100 is utilized tomanipulate tissue. Tissue from the wall of a hollow organ, such as forexample the stomach, is formed into plications, such as plication P1.Plication P1 is formed by gathering or manipulating tissue of the wallof the organ with end effecter 200 into a fold and piercing the foldedtissue with needle 206 of end effecter 200. Needle 206 includes suture312 and a suture based implant or pledget 314 associated therewith.According to an embodiment, one end of suture 312 is attached to pledget314 and the other end of suture 312 remains free and outside thepatient. According to an alternative embodiment, both ends of suture 312remain free and outside the patient's body, however, pledget 314 isattached to suture at a predetermined location. Pledget 314 can beloosely attached or securely attached to suture 312 by a knot, a clip,integral with suture 312, combinations thereof, or the like. Followingimplantation of pledget 314, a second pledget 316 is positioned withrespect to suture 312. Second pledget 316 is preferable positioned withrespect to suture 312 outside the body, however, second pledget 316 canbe positioned onto suture 12 inside the hollow organ. Second pledget 316is then moved into the hollow organ to be manipulated, a second fold oftissue or plication P2 is formed with the endoluminal or endoscopicsurgical device 100 and plication P2 is pierced with needle 206 of theendoscope 100. When plication P2 is pierced, suture 312 is pushedthrough plication P2, thereby, bringing pledget 316 into positionadjacent a side of plication P2. Following positioning of pledgets 314and 316, suture 312 is tightened such that plication P1 and plication P2are drawn together. Preferably, pledget 314 and pledget 316 arepositioned on opposing sides of plication P1 and P2, respectively. In analternative embodiment, pledget 314 and pledget 316 are positioned onthe same side of plication P1 and plication P2. After suture 312 istightened such that plication P1 and plication P2 are approximatedtogether, suture 312 is fixed. According to alternative embodiments,suture 312 can be either removably fixed or irremovably fixed to holdplication P1 and plication P2 in position. Suture 312 can be fixed witha knot, a suture clip, fused together, combinations thereof, or thelike. Furthermore, a predetermined pressure can be applied through thetightening of suture 312 such as to generate a predetermined treatmentcondition between the plications. According to some embodiments, thisprocedure is performed in the stomach of a patient. According to oneembodiment of treating a stomach condition, plication P1 and plicationP2 are formed approximately 2 cm from gastro-esophageal (GE) junction310. According to alternative embodiments, plication P1 and plication P2are formed between 2 cm and 5 cm from GE junction 310. Where the stomachcondition to be treated requires enhancement or replacement of thegastric valve, such plications are preferably located in cooperativerelationship with the GE junction to form an artificial gastric valve.

According to alternative embodiments, pledgets 314 and 316 may or maynot be used to form plications P1 and P2, respectively. It should beappreciated that depending on a condition to be treated, tissue typebeing treated, location of treatment, size or area to be treated,combinations thereof, and the like, pledgets 314 and 316 may not benecessary, thereby, using suture 312 to form plications P1 and P2 andtighten plications P1 and P2 together. In some embodiments, multiplepledgets can be implanted adjacent one another such as to treat a largetissue disturbance, such as a large incision, re-incision, necroticsite, fistula, combinations thereof, or the like.

In some embodiments, a patch 318 can be introduced with endoluminaldevice 100 into the organ to be treated. Patch 318 can be associatedwith a tissue engaging portion of the device and placed on the wall ofthe organ when the tissue engaging portions grasp the wall to form theplication. In some embodiments, patch 318 may be coupled with aplication, such as plication P2, through the securing implant such aspledget 316. In one exemplary embodiment, patch 318 may be formed as aresilient, clip-like member having at least two arms that can be securedto a plication previously formed by manipulating the tissue with theendoluminal device 100. As shown, for example, in FIG. 3, piercing ofthe tissue is not required for securing such an embodiment. According toalternative embodiments, patch 318 can be attached at a plurality oflocations to the wall of the organ. Patch 318 can increase the integrityof the organ. In some embodiments, patch 318 includes therapeutic agentssuch as, for example, antibiotics, drugs, inhibiting agents,anti-inflammatory agents, combinations thereof, and the like. Thetherapeutic agents can be coated on patch 318 or they can be dispersedthroughout the material that forms patch 318. Patch 318 can also befabricated from non-absorbable or bio-resorbable materials. Othertreatment devices as described below also my be employed.

Referring now to FIG. 4, end effecter 200 is shown having first arm 402and second arm 404. First arm 402 and second arm 404 are configured toengage and. manipulate tissue. In some embodiments, second arm 404includes a tissue piercing needle 406. In some embodiments, implantdevice 410 includes suture 412 that is attached to implant 414. In someembodiments implant 414 can be, but is not limited to, a drug deliverydevice, such as for example a delayed delivery material, delayedabsorbable drug eluding material, selectively drug permeable material ormembrane, time release delivery device, combination thereof, or thelike. In alternative embodiments, implant 414 can be, but is not limitedto a stimulator device, such as for example, an electrical stimulationdevice, mechanical stimulation device, vibratory device, soundstimulation device, ultra-sound stimulation device, combinationsthereof, or the like. In some embodiments, the stimulation device can beconfigured to stimulate a sense of a patient. In a preferred embodiment,the sense stimulated by the stimulation device can be a sense of satietyin the patient such that the patient's desire for eating is subsided. Infurther alternative embodiments, implant 414 can be, but is not limitedto, a sensory device, such as for example, a device to monitor pH,pressure, temperature, salinity, hydration, cellular activity, proteinlevels, glucose levels, insulin levels, hormone levels, biologicalfunction, biological secretion, cellular uptake, cellular secretion,combinations thereof, and the like. In further embodiments, implant 414can be, but is not limited to, a device to control biological activity,such as for example, inter or intra cellular pH, temperature, salinity,cellular function, cellular excretion, cellular uptake, glucose levels,insulin levels, combinations thereof, and the like. In alternativeembodiments, suture 412 can be resorbable suture material ornon-resorbable suture material.

In some embodiments, first arm 402 and second arm 404 are positionedwith respect to tissue that is to be manipulated. The arms aremanipulated by actuating a control on endoluminal surgical device 100.When first arm 402 and second arm 404 are actuated, they move towardeach other and tissue positioned between the arms is engaged and piercedwith needle 406. In some embodiments, needle 406 is coupled with suture412, and suture 412 is attached to implant device 410. Followingactivation of the arms and piercing tissue with needle 406, suture 412is pierced through the tissue and extends through the tissue withimplant device 410 on one side of the pierced tissue and a free end ofsuture 412 on the other side of the pierced tissue. Alternatively,suture 412 can be formed as a loop to be secured around a natural orformed anatomical feature, such as a plication, utilizing first andsecond arms 402 and 404 without piercing the tissue.

According to FIG. 5, implant device 500 is shown implanted with respectto tissue of a patient. According to an embodiment, tissue, such asstomach wall tissue 504 and stomach mucosa 502 are formed into aplication 520. Plication 520 is affixed with an anchor object thatincludes pledgets 506 and 510. In some embodiments, pledgets 506 and 510can be coupled together with a tee bar 508 and suture 512 and in otherembodiments pledgets can be coupled together only with suture 512.Implant 514 is attached to the anchor object. According to someembodiments, as shown in FIG. 5, implant 514 can be integral withpledget 510, coupled with pledget 510, or removable coupled with pledget514. In some embodiments, the coupling between pledget 510 and implant514 can be degradable over a predetermined time such that implant 514become detached from pledget 510. According to other embodiments,implant 514 can be any of the implant devices, sensors, drugs, drugdelivery devices, monitors, control devices, combinations thereof, andthe like that are described herein and/or incorporated into thisapplication by reference.

Referring now to FIG. 6, end effecter 200 is shown having first arm 602and second arm 604. Second arm is shown having needle 606 for piercingtissue, however, as will be appreciated first arm 602 and second arm 604and the components associated therewith can be interchanged such thatneedle 606 could be associated with first arm 602, and the like. Needle606 is coupled or threaded with suture 612, which includes a pledget 610associated therewith. As shown in FIG. 6, first arm 602 is configured tocouple with implant 614. Implant 614 further includes an affixingportion 616 for engaging with needle 606 and coupling thereto to bindtissue therebetween. In some embodiments, implant 614 can be any of theimplant devices described herein or incorporated herein by reference. Inother embodiments, suture 612 and pledget 610 can be fabricatedaccording to other embodiments described herein or incorporated hereinby reference.

According to FIG. 7, a plication 720 can be formed from a tissue wall orlining 704 that may or may not include a mucosa 702. Plication 720 isformed from binding tissue 704 with an anchor object that includespledgets 706 and 710. In some embodiments, pledgets 706 and 710 can becoupled with suture 712 and tee bar 708. According to some embodiments,implant 714 can be implanted with anchor object by coupling implant 714between tissue wall 704 or tissue mucosa 702 and pledget 706.

According to other embodiments, as shown in FIG. 8, implant 814 can beimplanted on a tether such that implant 814 is relatively affixed totissue but not rigidly affixed to any particular tissue. According toFIG. 8, end effecter 200 includes first arm 802, second arm 804, andtissue retractor 806. Second arm 804 includes tissue piercing needle 808for piercing tissue and implanting implant 814. Needle 808 furtherincludes suture 812 for affixing tissue that is pierced by needed 808into a plication. Suture 812 can include pledget 810 for biasing againsttissue. In some embodiments, suture 812 extends further beyond pledget810 and couples with implant 814. In other embodiments, second suture816 extends from pledget 810 and couples with implant 814. According tosuch embodiments, implant 814 is implanted into a patient and affixedinto a general location, however, implant 814 is semi-free to movewithin patient to the extent of tether provided between pledget 810 andimplant 814. FIG. 9 shows tethered implant 814 in an implanted positionwith respect to a tissue plication 920. According to some embodiments,plication 920 is formed by anchoring a plication of tissue with ananchor object that includes implant 814 tethered thereto by secondsuture 816.

Referring now to FIGS. 10-12C, a plication that forms an open pocket orbiologic tube is shown. In FIG. 10, an end effecter 200 has a first arm1002, a second arm 1004, and a tissue retractor 1014 and is used to forma tissue plication 1006, as described herein. Plication 1006 is formedby grasping tissue with retractor 1014 and manipulating first arm 1002and second arm 1004 together such that needle 1008 pierces the tissue.Suture 1012 is associated with needle 1008 such that suture 1012 ispierced through tissue with needle 1008. After piercing the tissue withneedle 1008, the tissue is retained on needle 1008. Referring now toFIG. 11, retractor 1014 is used a second time to grasp a second portionof tissue such that the tissue can be positioned with respect to firstarm 1002, second arm 1004, and needle 1008 and be pierced with needle1008 to form second plication 1102. By forming two adjacent plications1006 and 1102, an open pocket 1104 is formed. In some embodiments, animplant 1106 is housed in open pocket 1104.

In some embodiments, end effecter 200 can have multiple retractors 1014such that the retractor does not have to be removed from the tissueafter forming a first plication in order to form a second plication. Inother words, a first retractor 1014 can grasp tissue and form a firstplication while a second retractor grasps other tissue and forms asecond plication. Next, the two plications can be anchored together suchthat an open pocket 1104 is formed therebetween. In yet otherembodiments, tissue graspers are introduced into the surgical sitepercutaneously for grasping tissue and manipulating it into adjacentplications that form the tube or open pocket 1104. In some embodiments,the tissue graspers pull tissue around the shaft 102 of the surgicaldevice and position the tissue for implantation of the anchor object.Next, an anchor object is implanted to fasten the plications around theshaft of the surgical device. After the desired number of plications arefixed around the shaft of the surgical device, the end effecter 200 isstraightened such as to be axially aligned with shaft 102 and the shaft102 and end effecter 200 are removed through the open pocket 1104 of thetissue plications, leaving behind open pocket 1104, or as shown in FIGS.12B and 12C artificial tissue tube 1250.

According to some embodiments, as shown in FIG. 12A, tissue 1220 thatforms pocket 1104 between plications 1006 and 1102 may be tissue thatrequires treatment or can be used for locating a treatment. According tosuch embodiments, implant 1106 positioned in pocket 1104 is configuredto treat tissue 1220 or otherwise provide treatment to surroundingareas. In other embodiments, tissue 1220 can be removed following thedouble plication procedure described with respect to FIGS. 10-12A. Inother embodiments, tissue 1220 may dissolve or resorb following thedouble plication procedure.

In other embodiments, multiple double plication procedures, such as thedouble plication procedure described with respect to FIGS. 10-12 can beperformed on the same tissue, in the same organ, or the like. In someembodiments, as shown in FIGS. 12B-12C axially aligned double plications1240, 1242, 1244, and 1246 can be positioned adjacent to each other suchthat each open pocket 1104, formed between the plications 1006 and 1102,is generally aligned and forms an artificial biological tube 1250. Insome embodiments, artificial biological tube 1250 is formed by drawingeach double plication together. In some embodiments, each plication1240, 1242, 1244, and/or 1246 can be drawn together using surgical glue,suture material, surgical wire, staples, scoring the tissue such thatthe tissue reforms together, combinations thereof, or the like.

In some embodiments, vertically aligned double plications 1240, 1242,and 1244 are positioned, beginning at or distally near thegastro-esophageal-junction (GEJ) 1252 and extend into the stomach,thereby forming an artificial GEJ or gastric tube 1250. In someembodiments, when the artificial gastric tube is flaccid, i.e., empty,the artificial gastric tube acts as a gastric flap or valve forprotecting the esophagus from gastric fluids. Thus, the formation ofsuch an artificial gastric tube can be a treatment for gastro-esophagealreflux disorder (GERD). In other embodiments, the formation of anartificial gastric tube can be a technique for gastric reconstruction orreduction surgery. According to such embodiments, the formation of suchan artificial gastric tube effectively reduces the volume of the stomachof a patient, and thereby, stimulates the stomach into providing a senseof satiety with consumption of a smaller amount of food. According tosome embodiments, between 1 and about 10 plications are positionedadjacent each other to form artificial tube 1250. In other embodiments,between 1 and about 8 plications are positioned adjacent each other toform artificial tube 1250. In yet other embodiments, between 1 and about5 plications are positioned adjacent each other to form artificial tube1250. In yet other embodiments, between 1 and about 3 plications arepositioned adjacent each other to form artificial tube 1250. In stillother embodiments, a single plication is positioned adjacent the GEJ toform artificial tube 1250 or GERD treatment. According to otherembodiments, between about 5 and about 8 plications are positionedadjacent each other to form artificial tube 1250. According to someembodiments, when artificial tube 1250 is formed with between one andtwo tissue plications, artificial tube 1250 is about 1 cm in length. Inother embodiments, when artificial tube 1250 includes between about 10to about 20 tissue plications, artificial tube 1250 is about 10 cm inlength. In some embodiments, the diameter of artificial tube 1250 isbetween about 0.2 cm and about 10 cm. In other embodiments, the diameterof artificial tube 1250 is between about 0.5 cm and about 5 cm. In someembodiments, the diameter of artificial tube 1250 is between about 0.5cm and about 3 cm. In some embodiments, the diameter of artificial tube1250 is between about 0.5 cm and about 2 cm.

According to another embodiment, an implant device 1306 can be implantedonto tissue 1302 with multiple attachments, as shown in FIGS. 13A and13B. According to some embodiments as shown in FIG. 13A, an implant 1306can be located or held in position by coupling retractors 1304A-1304D totissue 1302 and/or implant device 1306. In some embodiments, as shown inFIG. 13B, implant 1306 may be such a shape or dimension that multipleanchor implants are required for proper or secure attachment of implant1306 to tissue 1302. As shown in FIG. 13B, multiple anchors 1308A-1308Dare implanted through tissue 1302 and implant 1306 to affix implant 1306as desired to tissue 1302. According to some embodiments, anchors1308A-1308D include pledgets 1310 and suture 1312. According to someembodiments, pledgets 1310 and suture 1312 can be fabricated in accordwith and from the materials of other pledgets and sutures describedherein and incorporated herein by reference.

Referring now to FIG. 14, anchor implant 1400 includes a coupling 1402and pledgets 506 and 510 coupled together by suture 512. Anchor implant1400 is configured to couple tissue 502, 504 to itself or to animplanted device. According to some embodiments, coupling 1402 isconfigured to provide a site on anchor implant 1400 for attaching animplantable device, mechanical tool, drug eluding device, sensor, otherdevice described or incorporated herein, combinations thereof, or thelike. In some embodiments, coupling 1402 can be, but is not limited to ahook, clip, Velcro, magnet, loop, combinations thereof, or the like.According to some embodiments, coupling 1402 can be formed from anon-resorbable polymer, resorbable polymer, biodegradable polymer, drugeluding polymer, stainless steel, titanium, cobalt chromium, surgicalmaterial, combinations thereof, or the like.

According to another embodiment, as shown in FIG. 17, endoluminalsurgical device 100 includes guide wire 1702 that includes tissueengaging retractor tip 1704. According to some embodiments, tissueengaging retractor tip 1704 is configured to releasable attach to tissueat a site near where an implant attachment site is targeted. In someembodiments, tissue engaging retractor tip 1704 can be, but is notlimited to a cork-screw type design, screw threads, a hook, a loop,jaws, locking jaws, combinations thereof, and the like. In use, having aguide wire 1702 that can attach to tissue or target a tissue at or nearan implant site can help direct where the implant device will pass andincreases the efficiency and effectiveness of surgical proceduresbecause the path that the device is require to pass is less rigorousand/or straighter.

Referring now to FIGS. 15A and 15B, an adjustable implantable device1500 is shown. In some embodiments, adjustable implantable device 1500includes anchor implants 1506 and 1508, however, the number of anchorimplants used in practice can vary to what is necessary for a particularprocedure being performed, corrected, or desired. In some embodiments,anchor implants include pledgets 1510 connected by suture 1512. In someembodiments, anchor implant 1506 is coupled with adjustment mechanism1514 by suture 1516 and anchor implant 1508 is coupled with adjustmentmechanism 1514 by suture 1518. Adjustment mechanism 1514 is configuredto adjust a physical parameter, such as for example, length, width,diameter, rotational axis, combinations thereof, or the like, inresponse to stimulation. In a preferred embodiment, adjustment mechanism1514 linearly shortens in response to a predetermined stimulation. Insome embodiments, a predetermined stimulation can be, but is not limitedto, a radio frequency, ultra-sound, mechanical force, pressure, directmechanical manipulation, magnetic force, chemical interaction, enzymeinteraction, fluid, temperature, biological fluid, cellular interaction,cellular by-product, inter-cellular constituent, intra-cellularconstituent, food, digestion by-product, time, combinations thereof, orthe like.

In some embodiments, adjustable implant device 1500 is implanted intothe tissue surrounding the gastro-esophageal-junction (GEJ). Having theadjustable implant device 1500 implanted in or near the GEJ allows theadjustable implant device 1500 to assist or augment the natural functionof the GEJ. According to an embodiment, in a relaxed state adjustableimplant device 1500 leaves the GEJ in an open state such that food,liquids, or the like can be passed from the esophagus into the stomachof a patient. However, following activation, adjustable mechanism 1514shortens and, thereby, tightens the GEJ such that gastric fluids areblocked from passing from the stomach into the esophagus and causing orworsening a patient's GERD condition. In some embodiments, adjustablemechanism 1514 can be a threaded mechanism, a coil mechanism, a springmechanism, a magnetic mechanism, a ratchet mechanism, memory material,piezoelectric material, temperature sensitive material, combinationsthereof, or the like.

In an alternative embodiment, adjustable implant device 1500 can beimplanted in a stomach of a patient. Implanting adjustable implantdevice 1500 into a stomach allows a patient or physician to reversiblyand/or temporarily restrict the volume of the stomach of a patient inresponse to a predetermined stimulus. According to some embodimentsadjustable implant device 1500, when implanted in the stomach of apatient, can be retracted or adjusted prior to consuming food andthereby act as a temporary gastric restriction device. In someembodiments, adjustable implant device 1500 can be configured to respondto a digestive by-product, a cellular excretion, particular gastricfluids, an external stimulation, combinations thereof, or the like. Itwill be appreciated that adjustable implant device 1500 can be implantedin many locations in a patient, such as but not limited to, anysphincter, tubular organ such as the intestine, muscle, skeletal system,combinations thereof, or the like.

Referring now to FIG. 16, a surgical stabilization system is shown.According to some surgical procedures a surgical device needs to beinserted through tissue, a tissue wall such as an abdominal wall, anorgan wall such as the stomach, or the like. Often, when performing suchsurgical procedures a surgeon loses much control over a working end of asurgical instrument after the instrument has been passed through thetissue wall. According to an embodiment of the present invention,devices and mechanisms for improving surgical dexterity includesattaching stabilizers such as stabilizers 1406, 1414, and 1422 to tissue1402 and shaft of implant device 102. According to alternativeembodiments, more or less stabilizers can be utilized depending therequirements of a particular situation. For simplicity sake only onestabilizer will be described, however, it will be appreciated that eachstabilizer includes generally the same construction. According to someembodiments, a stabilizer, such as stabilizer 1406 for example, includesa tissue anchor end and a device anchor end. The tissue anchor endincludes pledgets 1416 and 1417 connected by suture material 1418.Pledgets 1416 and 1417 and suture material 1418 can be implantedaccording to methods and with devices disclosed herein or incorporatedherein by reference. Pledget 1417 is further connected to line 1420 thatextends from pledget 1417 to device 102. Line 1420 can be, but is notlimited to, suture material, wire, rods, k-wires, t-bars, or othersurgical material or devices that can support tension, pressure, and/ortorque. According to some embodiments, the device anchoring end ofstabilization 1418 can be configured to couple to an attachment ondevice 102 such that a force applied to stabilizer 1418 can betranslated to device 102 and/or manipulation force applied to device 102can be leveraged over and around stabilization 1418. It will beappreciated that stabilization devices can be implanted as desired toassist in manipulating surgical device 102.

1. An endoscopic treatment method, comprising: introducing an endoscopicdevice into a lumen of a patient without creating an incision in thepatient's skin; introducing a treatment device into the lumen; engaginga wall of the lumen with an end effecter of the endoscopic device;forming at least one first plication in the wall of the lumen; formingat least one second plication in the wall of the lumen adjacent thefirst plication; coupling the first plication with the second plicationto thereby form at least one first double plication; wherein an openpocket is formed between the first plication and the second plication;wherein the double plication is positioned in cooperative relationshipwith the patient's gastro-esophageal-junction so as to form anartificial gastric valve.
 2. An endoscopic treatment method, comprising:introducing an endoscopic device into a lumen of a patient withoutcreating an incision in the patient's skin; introducing a treatmentdevice into the lumen; engaging a wall of the lumen with an end effecterof the endoscopic device; forming at least one first plication in thewall of the lumen; forming at least one second plication in the wall ofthe lumen adjacent the first plication; coupling the first plicationwith the second plication to thereby form at least one first doubleplication, wherein an open pocket is formed between the first plicationand the second plication; and coupling an implant device with the firstor second plication.
 3. The method of claim 2, wherein the implantdevice is a drug delivery device.
 4. The method of claim 2, wherein theimplant device is selected from the group consisting of an electricalstimulation device, a mechanical stimulation device, a vibratory device,a sound device, an ultra-sound device, a chemical stimulation device, aneuro-transmitter stimulation device, a thermal stimulation device, asensory stimulation device, and combinations thereof.
 5. An endoscopictreatment method, comprising: introducing an endoscopic device into alumen of a patient without creating an incision in the patient's skin;introducing a treatment device into the lumen; engaging a wall of thelumen with an end effecter of the endoscopic device; forming at leastfirst and second plications in the wall of the lumen such that at leastfirst and second open pockets are formed in the wall of the lumen;wherein the plications are adjacent, and wherein the open pockets areaxially aligned.